Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments mm-121 (sar256212) + erlotinib, erlotinib
Phase phase 1/phase 2
Target EGFR
Sponsor Merrimack Pharmaceuticals
Collaborator Sanofi
Start date February 2010
End date November 2013
Trial size 260 participants
Trial identifier NCT00994123, MM-121-01-101 (ARD11585)

Summary

A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mm-121 (sar256212) + erlotinib MM-121 (SAR256212) + Tarceva
MM-121 (SAR256212) = intravenous solution erlotinib = daily oral tablet
(Active Comparator)
erlotinib Tarceva
erlotinib = daily oral tablet

Primary Outcomes

Measure
Phase 1: To determine the recommended Phase 2 dose of the MM-121 + erlotinib combination based upon either the maximum tolerated dose (MTD) or the maximum feasible dose of the combination in patients with NSCLC.
time frame: June 2011

Secondary Outcomes

Measure
Phase 2: To estimate the progression-free survival of the MM-121 + erlotinib combination in patients with NSCLC.
time frame: December 2012

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with locally advanced or metastatic non-small cell lung cancer. - Patients must be >/= 18 years of age. - Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function. Exclusion Criteria: - Patients with a recent history (within 5 years) of another malignancy. - Patients who are pregnant or nursing. - Patients with clinically significant heart failure. - Patients with clinically significant eye or gastrointestinal abnormalities.

Additional Information

Official title A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer
Description Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy. Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Merrimack Pharmaceuticals.